Neovascular age-related macular degeneration MedDRA version: 16.1 Level: LLT Classification code 10071129 Term: Neovascular age-related macular degeneration System Organ Class: 100000004853
Conditions
Interventions
Product Name: Fovista
Product Code: E10030
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Fovista
CAS Number: 144930-73-1
Current Sponsor code: E10030
Other descriptive name: E10030
Sponsors
Barcelona Macula Foundation Research for Vision
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subfoveal choroidal neovascularization (CNV) due to AMD as documented by fluorescein angiogram. - Best corrected visual acuity in the study eye between 20/40 and 20/400, inclusive. The VA must be re-confirmed at Day 1 prior to randomization. - Active CNV must compromise at least 25% of the lesion as measured on fluorescein angiogram (including blood, neovascularization, and scar/atrophy) - Presence on OCT of subretinal, intraretinal or sub-RPE fluid and/or subretinal thickening/reflectivity consistent with active CNV. - Clear ocular media and adequate pupillary dilatation to allow collection of fundus photographs and fluorescein angiograms of a sufficient quality to be analyzed by the central reading center. - Intraocular pressure (IOP) of 21 mmHg or less. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: - More than 25% of the total lesion size made up of scarring or atrophy. Subjects with subfoveal scar or subfoveal atrophy are excluded. - More than 50% of the total lesion size consisting of subretinal hemorrhage. - Presence of retinal angiomatous proliferation (RAP). - Presence of significant serous pigment epithelial detachments (PEDs), such as large PEDs that constitute greater than 50% of the total lesion or have a vertical height of ? 400 µm. - Presence of pigment epithelial tears or rips. - Presence of intraocular inflammation (? trace cell or flare), significant epiretinal membrane (causing distortion of macular anatomy and/or opacification), significant vitreomacular traction (causing distortion of macular anatomy), macular hole or vitreous hemorrhage. - Aphakia or absence of the posterior capsule. Absence of an intact posterior capsule is allowed if it occurred as a result of YAG laser posterior capsulotomy in association with prior posterior chamber IOL implantation. - History of idiopathic or autoimmune-associated uveitis in either eye. - Significant media opacities, including cataract, which might interfere with visual acuity, assessment of toxicity, or fundus photography in the study eye. Subjects should not be entered if there is likelihood that they will require cataract surgery in the study eye in the next 12 months. - Presence of other causes of choroidal neovascularization, including pathologic myopia (spherical equivalent of -8 diopters or more, or axial length of 25mm or more), the ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, and multifocal choroiditis. - Any intraocular surgery or thermal laser within three (3) months of trial entry. Any prior thermal laser in the macular region, regardless of indication. - Any ocular or periocular infection in the past twelve (12) weeks. - History of any of the following conditions or procedures in the study eye: Rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, corneal transplant. - Previous therapeutic radiation in the region of the study eye.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish the safety and tolerability of intravitreous administration of altering regimens of Fovista? (Anti-PDGF-B pegylated aptamer) administered in combination with Anti-VEGF therapy (Lucentis®, Avastin® or Eylea®) in subjects with subfoveal neovascular age-related macular degeneration. . Safety endpoints include adverse events, vital signs, ophthalmic variables [ophthalmic examination, intraocular pressure (IOP), fluorescein angiogram (FA), optical coherence tomography (OCT)], ECG, and laboratory variables.;Secondary Objective: - Mean change in area of fibrosis as assessed by fibrosis on fundus photography and evaluation of subretinal hyper-reflective material on OCT at 24 months - Mean number of total combination therapy treatments at 9 months - Mean change in visual acuity (ETDRS letters) at 9 months;Primary end point(s): To evaluate the safety, tolerability and development of subfoveal fibrosis by intravitreal administration of altering regimens of FovistaTM (Anti-PDGF-B pegylated aptamer) and Anti-VEGF therapy (Lucentis®, Avastin® or Eylea®) in subjects with neovascular age-related macular degeneration;Timepoint(s) of evaluation of this end point: Following Month 24 visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Mean change in area of fibrosis as assessed by fibrosis on fundus photography and evaluation of subretinal hyper-reflective material on OCT at 24 months - Mean number of total combination therapy treatments at 9 months - Mean change in visual acuity (ETDRS letters) at 9 months;Timepoint(s) of evaluation of this end point: Following Month 9 and 24 visit | — |
Countries
Spain
Contacts
Public ContactElisabet Molina
Trial Form Support, S.L.
Outcome results
None listed